Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE...

FDA Device Recall #Z-0413-2026 — Class II — October 7, 2025

Recall Summary

Recall Number Z-0413-2026
Classification Class II — Moderate risk
Date Initiated October 7, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Trividia Health, Inc.
Location Ft Lauderdale, FL
Product Type Devices
Quantity 601 units

Product Description

Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.

Reason for Recall

Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.

Distribution Pattern

US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.

Lot / Code Information

Model/Catalog Number: RE4011-01. UDI-DI (Meter Kit): 00087701426254. UDI-DI (Meter): 00021292007690. Serial Numbers: T13908301, T13908302, T13908303, T13908304, T13908305, T13908306, T13908307, T13908308, T13908309, T13908310, T13908311, T13908312, T13908313, T13908314, T13908315, T13908316, T13908317, T13908318, T13908319, T13908320, T13908321, T13908322, T13908323, T13908324, T13908325, T13908326, T13908327, T13908328, T13908329, T13908330, T13908331, T13908332, T13908333, T13908335, T13908336, T13908337, T13908338, T13908339, T13908340, T13908341, T13908342, T13908343, T13908344, T13908345, T13908346, T13908347, T13908348, T13908349, T13908350, T13908351, T13908352, T13908353, T13908354, T13908355, T13908356, T13908357, T13908358, T13908359, T13908360, T13908361, T13908362, T13908363, T13908364, T13908365, T13908366, T13908367, T13908368, T13908369, T13908370, T13908371, T13908372, T13908373, T13908374, T13908375, T13908376, T13908377, T13908378, T13908379, T13908380, T13908381, T13908382, T13908383, T13908384, T13908385, T13908386, T13908387, T13908388, T13908389, T13908390, T13908391, T13908392, T13908393, T13908394, T13908395, T13908396, T13908397, T13908398, T13908399, T13908400, T13909501, T13909502, T13909503, T13909504, T13909505, T13909506, T13909507, T13909508, T13909509, T13909510, T13909511, T13909512, T13909513, T13909514, T13909515, T13909516, T13909517, T13909518, T13909519, T13909520, T13909521, T13909522, T13909523, T13909524, T13909525, T13909526, T13909527, T13909528, T13909529, T13909530, T13909531, T13909532, T13909533, T13909534, T13909535, T13909536, T13909537, T13909538, T13909539, T13909540, T13909541, T13909542, T13909543, T13909544, T13909545, T13909546, T13909547, T13909548, T13909549, T13909550, T13909551, T13909552, T13909553, T13909554, T13909555, T13909556, T13909557, T13909558, T13909559, T13909560, T13909561, T13909562, T13909563, T13909564, T13909565, T13909566, T13909567, T13909568, T13909569, T13909570, T13909571, T13909572, T13909573, T13909574, T13909575, T13909576, T13909577, T13909578, T13909579, T13909580, T13909581, T13909582, T13909583, T13909584, T13909586, T13909587, T13909588, T13909589, T13909590, T13909591, T13909592, T13909593, T13909594, T13909595, T13909596, T13909597, T13909598, T13909599, T13909600, T13909981, T13909982, T13909983, T13909984, T13909985, T13909987, T13909988, T13909989, T13909990, T13911201, T13911203, T13911204, T13911205, T13911206, T13911207, T13911208, T13911209, T13911210, T13911211, T13911212, T13911213, T13911214, T13911215, T13911216, T13911217, T13911219, T13911220, T13911221, T13911222, T13911223, T13911224, T13911225, T13911226, T13911227, T13911228, T13911229, T13911230, T13911231, T13911232, T13911233, T13911236, T13911237, T13911238, T13911239, T13911240, T13911241, T13911242, T13911243, T13911244, T13911245, T13911246, T13911247, T13911248, T13911249, T13911250, T13911251, T13911252, T13911253, T13911254, T13911255, T13911256, T13911257, T13911258, T13911259, T13911260, T13911261, T13911262, T13911263, T13911264, T13911265, T13911266, T13911267, T13911268, T13911269, T13911270, T13911271, T13911272, T13911273, T13911274, T13911275, T13911276, T13911277, T13911278, T13911279, T13911280, T13911281, T13911282, T13911283, T13911284, T13911285, T13911286, T13911287, T13911288, T13911289, T13911290, T13911291, T13911292, T13911293, T13911294, T13911295, T13911296, T13911297, T13911298, T13911299, T13911300, T13911501, T13911502, T13911503, T13911504, T13911505, T13911506, T13911507, T13911508, T13911509, T13911510, T13911511, T13911512, T13911513, T13911514, T13911515, T13911516, T13911517, T13911518, T13911519, T13911520, T13911521, T13911522, T13911523, T13911524, T13911525, T13911526, T13911527, T13911528, T13911529, T13911530, T13911531, T13911532, T13911533, T13911534, T13911535, T13911536, T13911537, T13911538, T13911539, T13911540, T13911541, T13911542, T13911543, T13911544, T13911545, T13911546, T13911547, T13911548, T13911549, T13911550, T13911551, T13911552, T13911553, T13911554, T13911555, T13911556, T13911557, T13911558, T13911559, T13911560, T13911561, T13911562, T13911563, T13911564, T13911565, T13911566, T13911567, T13911568, T13911569, T13911570, T13911571, T13911572, T13911573, T13911574, T13911575, T13911576, T13911577, T13911578, T13911579, T13911580, T13911581, T13911582, T13911583, T13911584, T13911585, T13911586, T13911587, T13911588, T13911589, T13911590, T13911591, T13911592, T13911593, T13911594, T13911595, T13911596, T13911597, T13911598, T13911599, T13911600, T13912001, T13912002, T13912003, T13912004, T13912005, T13912006, T13912007, T13912008, T13912009, T13912010, T13912011, T13912012, T13912013, T13912014, T13912015, T13912016, T13912017, T13912018, T13912019, T13912020, T13912021, T13912022, T13912023, T13912024, T13912025, T13912026, T13912027, T13912028, T13912029, T13912030, T13912031, T13912032, T13912033, T13912034, T13912035, T13912036, T13912037, T13912038, T13912039, T13912040, T13912041, T13912042, T13912043, T13912044, T13912045, T13912046, T13912047, T13912048, T13912049, T13912050, T13912051, T13912052, T13912053, T13912054, T13912056, T13912057, T13912058, T13912059, T13912060, T13912061, T13912062, T13912063, T13912064, T13912065, T13912066, T13912067, T13912068, T13912069, T13912070, T13912071, T13912072, T13912073, T13912074, T13912075, T13912076, T13912077, T13912078, T13912079, T13912080, T13912081, T13912082, T13912083, T13912084, T13912085, T13912086, T13912087, T13912088, T13912089, T13912090, T13912091, T13912092, T13912093, T13912094, T13912095, T13912096, T13912097, T13912098, T13912099, T13912100, T13912201, T13912202, T13912203, T13912204, T13912205, T13912206, T13912207, T13912208, T13912209, T13912210, T13912211, T13912212, T13912213, T13912214, T13912215, T13912216, T13912217, T13912218, T13912219, T13912220, T13912221, T13912222, T13912223, T13912224, T13912225, T13912226, T13912227, T13912228, T13912229, T13912230, T13912231, T13912232, T13912233, T13912234, T13912235, T13912236, T13912237, T13912238, T13912239, T13912240, T13912241, T13912242, T13912244, T13912245, T13912246, T13912247, T13912248, T13912249, T13912250, T13912251, T13912252, T13912253, T13912254, T13912255, T13912256, T13912257, T13912258, T13912259, T13912260, T13912261, T13912262, T13912263, T13912264, T13912265, T13912266, T13912267, T13912268, T13912269, T13912270, T13912271, T13912272, T13912273, T13912274, T13912275, T13912276, T13912277, T13912278, T13912279, T13912280, T13912281, T13912282, T13912283, T13912284, T13912285, T13912286, T13912287, T13912288, T13912289, T13912290, T13912291, T13912292, T13912293, T13912294, T13912295, T13912296, T13912297, T13912298, T13912299, T13912300. Expiration Date: 02/21/2030.

Other Recalls from Trividia Health, Inc.

Recall # Classification Product Date
Z-1546-2026 Class I Owner's Booklets and Instructions for Use that ... Feb 6, 2026
Z-1547-2026 Class I Owner's Booklets and Instructions for Use that ... Feb 6, 2026
Z-1548-2026 Class I Owner's Booklets and Instructions for Use that ... Feb 6, 2026
Z-1545-2026 Class I Owner's Booklets and Instructions for Use that ... Feb 6, 2026
Z-2201-2020 Class II TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTE... Apr 20, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.